Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

NCT ID: NCT03237442

Last Updated: 2017-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-06-30

Brief Summary

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Ocular chemical burn is one of the causes of vision loss in China, and there are no satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal burn in human.

Detailed Description

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Conditions

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Ocular Corneal Burn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group 1

Group Type EXPERIMENTAL

human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

human UC-MSCs: 0.2ml(about 2\*10\^6 cells) subconjunctival injection

group 2

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type BIOLOGICAL

Saline injection

Interventions

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human umbilical cord mesenchymal stem cells

human UC-MSCs: 0.2ml(about 2\*10\^6 cells) subconjunctival injection

Intervention Type BIOLOGICAL

placebo

Saline injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* must be ocular burns including chemically burned or the thermally burned;
* the subjects are willing to accept this research, and promise to coordinate with the researchers during the follow up period;
* the subjects should abide by the laws and rules of the study.

Exclusion Criteria

* the visual acuity is blind in any of the eye;
* have corneal perforation or have the corneal perforation tendency;
* have been accepted surgery on eyeball after trauma;
* IOP\>=25 mmHg even after antiglaucoma;
* have the history of other corneal disease or surgery;
* have the history of radiotherapy or surgery in the eyeball;
* associated with corneal ulcer or endoophthalmitis;
* uncontrolled hypertension(\>=150/95 mmHg);
* abnormal liver and renal function;
* the pregnant women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Wanling Chen

Role: CONTACT

0086-20-37792600

Facility Contacts

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Yanyan Ma

Role: primary

Other Identifiers

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SSCST-MSC-OCB-01

Identifier Type: -

Identifier Source: org_study_id

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